The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Thank you, gentlemen, for spending some time with us to walk us through the story. Why don't we start, I guess, with a brief overview of Exelixis.
Obviously, you've been around a while, accomplished a lot. You have commercial assets and a lot of stuff the pipeline will talk about. I think would
help to get an overview of the company.
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Yes. And I think that vision of Exelixis 3.0, obviously resonated with investors. I think that's what your stock really broke out of a trading range you
have been in for quite a while, and it's done well even despite the hard times, so a lot of the colleagues in biotech of experience. So congratulations
on that.
Chris, maybe we could talk just a little bit about the guidance, the cabo guidance in 2025. Can you just give us what's behind those numbers, some
of the pushes and pulls?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Right. Why don't we talk a little bit about cabo and the net indication? You originally had an AdCom schedule, the PDUFA date is April 3, and then
it was essentially canceled. And I believe that was before a lot of the government cuts that have come down subsequently. So any color that you
can give to us investors about what drove the initial decision to schedule that and then the subsequent vision to cancel it.
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. Have those discussions included label negotiations with the FDA?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. You don't have net in your guidance at this point, but if approved, and you will give it. What will you have to do to expand the infrastructure
to repair for potential net?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. The $3 billion number that you pointed to in 2030, does look like consensus is supportive that you'll reach that number. How much is for
CRPC and that guidance number, the $3 billion.
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. Why don't we move to zanza? I think, obviously, a big part of fundamental, but also probably strategic value for the company is going to be
a viable tail to continue the success you've had with cabo. Can you just walk us through the profile of zanza versus cabo? Why don't we start there,
and then we'll talk about the development.
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MARCH 12, 2025 / 2:40PM, EXEL.OQ - Exelixis Inc at Leerink Partners Global Healthcare Conference
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. In terms of differentiation versus cabo, I think some investors were not convinced at some of the updates that there was a clear differentiation.
How important is it that in all these indications, some of which cabo is not approved, that you actually have that differentiation. I mean, can you --
I mean, obviously, a big part of Exelixis 3.0 is extending the tail on the IP of a very successful drug, which, like I said, I think, adds both strategic and
fundamental value. How important is it that there's a clear benefit for zanza over cabo to achieve that goal?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Right. I mean it seems to me the most relevant question is, can you get approved? And what the data will look like relative to other options in those
respect therapeutic areas?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. Can we talk -- that's obviously a very big milestone for the company STELLAR-303 in third line plus colorectal cancer. Can we talk a little bit
about the design of that trial? And how it's changed over the number of years?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: How does regorafenib do in liver mets versus non-liver mets?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. Third line plus colorectal cancer, obviously, a late-stage disease and a lot of colons, blood flow and lymphatic strength to the liver. What
percentage of the opportunity do you lose by excluding patients with liver mets, you think?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. What's your sense for investor expectations? Do you think that if you get the non-liver population, and it looks approvable in that indication,
but not in the patients with liver mets. Do you think that would be a (technical difficulty) for investors? Or do you think that's going to be enough
to -- you're positive, cattle's?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. Fair enough. The trial has also altered with RAS mutation versus wild type. Can you talk a little bit about the implications and the genesis of
that?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. Got it. We only have a couple of minutes left, and I want to make sure we talk about the other programs. What -- I guess, before we move to
some of the earlier pipeline, what about STELLAR-304. Can you just give us a rundown of that program and what kind of achieve?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. And it's going to be the PFS endpoint that comes up?
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MARCH 12, 2025 / 2:40PM, EXEL.OQ - Exelixis Inc at Leerink Partners Global Healthcare Conference
Question: Andrew Berens - Leerink Partners LLC - Analyst
: How important is OS and the regulatory decision?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Yes. Okay. Maybe just on the head and neck program for zanza, what do you assume as the contribution from head and neck? Because it's an area
we're very interested in. We have a number of companies that developing, and we think it's a pretty large opportunity. What are your assumptions
for zanza's potential there?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. Its risk adjusted or.
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. Yes. We see those multiples beyond that, especially based on the duration of some of these drugs that could expand the market. We only
have a few seconds. What in the early pipeline besides zanza is important to the overall strategy for the company going forward?
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MARCH 12, 2025 / 2:40PM, EXEL.OQ - Exelixis Inc at Leerink Partners Global Healthcare Conference
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. Well, we really appreciate the updates. Congrats on all the progress. You've got a big readouts this year, and we'll definitely be watching.
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